BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Caption Interpretation PCCP

    Reg #: 3016665037 · FEI: 3016665037 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CAPTION HEALTH
    Registration Number
    3016665037
    FEI Number
    3016665037
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 W 4th Ave, Suite 215
    City
    San Mateo
    State
    CA
    ZIP
    94402
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN220063

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan QVD

    Proprietary Names

    Caption Interpretation PCCP

    Establishment Types

    Manufacture Medical Device